RESISTANCE

High Barrier to Resistance Supported By 48-Week Data in GEMINI 1 & 2    

No patients receiving the components of DOVATO with confirmed virologic withdrawal across the pooled GEMINI 1 & GEMINI 2 trials had treatment-emergent INSTI or NRTI resistance substitutions through 48 weeks1*

0Cases of Resistance-Associated Substitutions in GEMINI 1 & 2 (48-Week Pooled Data)

 

Number of Patients

in Treatment Arm

Confirmed Virologic

Withdrawal, % (n)

Treatment-Emergent Substitutions With Detectable Decreased Susceptibility
INSTI NRTI
DOVATO

716

<1% (6)


0 0
DTG + TDF/FTC

717
<1% (4)


0 0

*The confirmed virologic withdrawal population was defined as either virologic nonresponse (a decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 12, with subsequent confirmation, unless plasma HIV-1 RNA is <200 copies/mL or confirmed plasma HIV-1 RNA levels >200 copies/mL on or after Week 24) or virologic rebound (confirmed rebound in plasma HIV-1 RNA levels to >200 copies/mL after prior confirmed suppression to <200 copies/mL).

DTG=dolutegravir; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; TDF=tenofovir disoproxil fumarate.    

Reference:

1. Cahn P, Sierra Madero J, Arribas J, et al; and GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155.

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